Good afternoon, everyone, and thank you for joining H.C. Wainwright's 26th Annual Global Investment Conference. My name is Eduardo Martinez. I am a biotech equity research associate at H.C. Wainwright, and it is my pleasure to introduce Mr. Kevin Moran, Chief Financial Officer at Vanda Pharmaceuticals. Mr. Moran, the floor is yours.
Thanks, Eduardo, and thanks to the entire H.C. Wainwright team for having us. Very much appreciate it. Very excited to talk to you about updates on Vanda and our future progress. Vanda Pharmaceuticals is a leading global biopharmaceutical company dedicated to innovating in the service of people's pursuit of happiness. We have three commercial products: Fanapt, which is approved for adults in schizophrenia and in adults in bipolar I disorder. Hetlioz, including both the Hetlioz oral capsules and Hetlioz LQ liquid formulation. The oral capsules are approved in the U.S. for adults with non-twenty-four-hour sleep-wake disorder and adults with nighttime sleep disturbances in Smith-Magenis syndrome. Additionally, Hetlioz oral capsules are approved in Europe for adults with non-twenty-four-hour sleep-wake disorder, and the Hetlioz LQ liquid formulation is approved in the U.S. for pediatric patients with nighttime sleep disturbances in Smith-Magenis syndrome.
Our third product is Ponvory, which is approved in multiple sclerosis in the U.S. and Canada, and we acquired from J&J for $100 million in December 2023. In addition to those commercial products, we have a very robust pipeline, including a number of recent and upcoming regulatory submissions, as well as multiple products that span a wide range of therapeutic areas and various stages of development. Finally, we are in a strong financial position. We ended the second quarter with approximately $390 million in cash and no debt. In a bit more detail on our commercial products. Again, Fanapt approved in the U.S. for the treatment of bipolar I disorder in adults and adults with schizophrenia.
In addition to those indications, we'll be pursuing FDA approval of milsaperidone, which is the active metabolite of iloperidone, Fanapt, for the treatment of adults with bipolar I disorder and schizophrenia, where we plan to submit an NDA to the FDA in early 2025. In addition to that, we plan to initiate a clinical program in major depressive disorder by the end of this year. Finally, on Fanapt, our phase III program for the long-acting injectable formulation is expected to be initiated also by the end of this year. On Hetlioz, again, our oral capsules are approved in the U.S. and Europe for the treatment of non-24-hour sleep-wake d isorder, and our oral capsules and Hetlioz LQ liquid formulation are approved in the U.S. for the treatment of nighttime sleep disturbances in Smith-Magenis syndrome.
In addition to those indications, we're pursuing FDA approvals for Hetlioz in the indications of insomnia and jet lag disorder, and on the Hetlioz LQ liquid formulation, which is not the subject of, current generic challengers, we plan to initiate a program in pediatric insomnia. Turning to our third product on Ponvory, again, approved for the treatment of relapsing forms of multiple sclerosis, and where we plan to file IND applications before the end of the year for both the treatment of psoriasis and the treatment of ulcerative colitis. Turning to our strategic focus. Vanda's focused on increasing revenue, both through organically our existing products, as well as potentially exploring future business development opportunities. We continue to advance our pipeline, including our late and early-stage programs, and have made investments in our emerging ASO platform.
We always have a focus on engagement directly with consumers, including increasing access and affordability for patients and engaging directly wherever possible. Turning now to our commercial priorities and milestones. Beginning with Fanapt, we've commenced our commercial launch of Fanapt in acute bipolar I disorder in the third quarter of this year. We continue to have a focus on the market for schizophrenia, where we've been in the market for some time. We're pursuing FDA approval for milsaperidone for the treatment of adults with both bipolar I disorder and schizophrenia, and we're looking to advance our milsaperidone major depressive disorder program, as well as our Fanapt long-acting injectable program. On Hetlioz, we're focused on retaining market share despite generic competition and doing so with a focus on patient loyalty.
We're focused on continuing growth for Hetlioz in SMS in the U.S. market and pursuing approval for Hetlioz in SMS in the European market. We're also pursuing FDA approvals for Hetlioz for the indications of insomnia and jet lag disorder, and as I mentioned, initiating a pediatric insomnia program for the Hetlioz LQ liquid formulation. On Ponvory, we also, in the third quarter, began our commercial efforts around the launch of Ponvory in multiple sclerosis, and we plan to file IND applications for the treatment of psoriasis and for the treatment of ulcerative colitis by the end of the year. And finally, on tradipitant, we're pursuing FDA approval for tradipitant in patients with gastroparesis, where we have a PDUFA date of September eighteenth, 2024, and we're pursuing FDA approval for tradipitant in patients with motion sickness, where we plan to file an NDA by the end of this year.
Turning now to our research and development programs, this is a view of our late-stage clinical development pipeline. In addition to this, there's a number of early-stage assets at various stages of development. As I mentioned, on the Fanapt side, we're pursuing the long-acting injectable formulation, where we plan to initiate a phase III trial by the end of this year. On milsaperidone, we have an upcoming NDA submission in early 2025 that will cover both schizophrenia and bipolar I disorder, and we plan to initiate a phase III program on major depressive disorder by the end of this year. On Hetlioz, we continue to pursue FDA approval for a number of indications, including jet lag disorder and insomnia, and we plan to initiate our pediatric Non-24 program, or pediatric insomnia program rather, by the end of this year for the liquid LQ formulation.
On Ponvory, again, we're pursuing psoriasis and ulcerative colitis, with IND applications expected to be filed by the end of this year. And on tradipitant, our gastroparesis PDUFA date, as I mentioned, is upcoming on September eighteenth, and our motion sickness NDA filing is expected by the end of the year. On Hetlioz lifecycle management, again, we've completed our programs on both jet lag disorder and insomnia. On DSPD or delayed sleep phase disorder, our phase 3 program has been initiated and is underway. On Non-24 pediatric disorder, our phase 3 clinical program is in preparation, and on pediatric insomnia, we are initiating our phase 3 program for the Hetlioz LQ liquid formulation. Turning to Fanapt.
First, on bipolar I disorder, as a reminder, we've completed our phase III program and announced positive results at the end of 2022 , submitted our sNDA in 2023 , and in April of this year, had Fanapt approved by the FDA for bipolar I disorder in adults. On the long-acting injectable formulation, we're expecting to initiate our phase III program by the end of the year, and the Fanapt LAI could reach the U.S. market after 2026 , and there are pending patent applications that, if issued, could extend exclusivity into the 2040s. On milsaperidone, again, the active metabolite of iloperidone, we plan to submit our new drug application in early 2025 , and we are pursuing in a clinical program major depressive disorder that is expected to be initiated by the end of this year. Turning now to tradipitant.
On gastroparesis, again, we're pursuing FDA approval for tradipitant in patients with gastroparesis. The NDA was accepted for filing in 2023 , and our PDUFA target action date is September eighteenth. As a reminder, we had a phase III study with results reported in February 2022 . That was a twelve-week study of approximately 200 patients stratified across both idiopathic and diabetic gastroparesis, and that followed a positive phase II study where results were reported in December of 2018 . On our motion sickness program, we've had three clinical trials, including two positive phase III trials, with the second phase III trial reporting results in May of this year, following the first phase III clinical trial results being reported in May of 2023 , and those two trials followed on the heels of our positive phase II study back in July of 2019 .
Now in a bit more detail on gastroparesis. Again, our two completed clinical studies are supportive of our NDA submission, which was accepted by the FDA. Gastroparesis itself represents a significant unmet medical need, with the last approved treatment option approved more than forty years ago, and the approved treatment option coming with a black box warning for tardive dyskinesia. In the U.S., there's estimated to be six million people suffering from gastroparesis, of which 600,000 are estimated to have been diagnosed, and for the only approved drug for gastroparesis, metoclopramide, there's approximately 300,000 prescriptions on a monthly basis, according to IQVIA. On the symptoms and clinical expression of gastroparesis, gastroparesis is characterized by chronic nausea, vomiting, delayed gastric emptying, and other GI symptoms.
On the chronic nausea, patients suffer with chronic debilitating nausea, vomiting, which can lead to weight loss and hospitalization, delayed gastric emptying, which may actually be the cause of some of the underlying symptoms, and other GI symptoms, including early satiety and abdominal pain. In a bit more detail on our clinical program, our phase II study, or the 2301 study, was a four-week study of approximately 150 adult patients stratified across both diabetic or idiopathic gastroparesis. Tradipitant in the trial was shown to be effective in improving nausea and the overall symptoms in patients with gastroparesis, and the efficacy established in the four-week double-blind phase was persistent in the open label phase. Our phase III study, or the 3301 study, was a twelve-week study of approximately 200 patients, again, stratified across diabetic or idiopathic gastroparesis.
And while the study did not meet its primary endpoint, when accounting for confounders, there was strong evidence of drug effect across a number of symptoms. And the open label phase remains open, with over 300 patients already enrolled. Finally, on our expanded access program, we initiated an expanded access program for patients requesting access to tradipitant outside of the clinical studies, and we continue to receive requests from patients reaching out to gain access to tradipitant, where we now have multiple patients who've continued to take tradipitant for beyond a year. On our phase II study, again, the study design was a four-week double-blind treatment, followed by an optional eight weeks of open label treatment.
It was run across 47 study sites in the U.S., with approximately 150 patients, and a number of assessments were conducted, including the primary endpoint, the patient-reported daily diary of nausea, vomiting, and other symptoms. Our phase III study was a similar design, although it was 12 weeks of double-blind treatment across 40 sites in the U.S., with approximately 200 patients randomized, again, across idiopathic and diabetic gastroparesis with the same assessments. Our pooled study results. Vanda completed a pooled analysis of the two clinical studies of tradipitant. The population was 342 patients, where we measured relevant clinical endpoints. Of note, both studies were large, multi-site, randomized, double-blind, placebo-controlled studies, and in the pooled analysis, tradipitant was shown to be superior to placebo in key clinical parameters, including the primary endpoint parameter of daily diary nausea.
The conclusion is that both studies demonstrate the efficacy of tradipitant in relieving the symptoms of gastroparesis. Now in a bit more detail on motion sickness. Nausea and vomiting are the core symptoms of motion sickness. These symptoms are the result of the sensory mismatch due to discordance between the actual and expected movement as perceived by various bodily symptoms. For Dramamine, which is the most commonly used treatment for motion sickness, there's approximately two to three million doses of Dramamine purchased each month in the U.S. On our phase III program, we first completed our phase II study that read out results in May of 2023 that was positive in preventing vomiting. Our second phase III that read out in May of 2024, also positive results in the prevention of vomiting.
Of note, the first study had a three-arm study, 85 mg, 170 mg, and placebo arms, and the second study had the same arms, with the primary endpoint being met on the 170 mg arm, and the 85 mg arm meeting the secondary endpoint, and again, with the studies now completed, our new drug application is expected to be submitted prior to the end of this year. In a bit more detail on the first phase III study, we had 365 participants across 34 boat trips, and the study spanned November 2021 to April of 2023. The boat trips were approximately 4-hour boat trips, with questionnaires of vomiting and nausea every 30 minutes.
The incidence of vomiting was significantly lower in tradipitant in both arms, as compared to placebo, with the higher dose, 170-mg arm, being approximately 18% vomiting, with the tradipitant 85-mg arm being approximately 19% vomiting, and those being compared to placebo, which had significantly higher vomiting at 44%. On the second phase III study, there were 316 participants across 20 boat trips. The study being conducted from September of 2023 through April of 2024. Again, four-hour boat trips with questionnaires every 30 minutes, and in this trial, the incidence of vomiting was significantly lower in the 170-mg arm, as with 10% vomiting. The tradipitant 85-mg arm being still significantly lower with 18% vomiting, and those both being compared to placebo with nearly 38% vomiting.
Turning now to our early-stage programs. We have a number of early-stage programs. A few of note here is our CFTR compounds. Our first is our CFTR activator, VSJ-110. We're currently conducting a phase II study for the treatment of dry eye, and that study is more than 50% enrolled. Our CFTR inhibitor, VPO-227, which was granted orphan drug designation by the FDA for the treatment of cholera. In addition to that, we have VTR-297, which is an HDAC inhibitor, currently in development for hematologic malignancies, where we have an ongoing phase II study at sites in the U.S. and Europe. In addition to that, we have a phase I study for the treatment of onychomycosis, which is a fungal infection of the nail, that was initiated earlier this year in April.
We also have VQW-765, which is, a compound that's currently in development for social performance anxiety, where we had a phase II study completed in December of 2022. In addition to those compounds, we have our ASO platform, where in September of 2022, we entered into a research and development agreement to jointly develop a set of ASO molecules, based on OliPass's proprietary modified peptide nucleic acids. And this platform will continue to be, an area where we make additional discovery and developments in the coming years. Finally, turning to our financial results. Our 2024 financial guidance includes total revenue of $180 million-$210 million, and year-end 2024 cash of $360 million-$390 million. As a reminder, we ended 2023 with just under $390 million of cash.
Our Q2 2024 financial highlights included $50.5 million of net product sales, which consisted of $23.2 million of Fanapt net product sales, $18.7 million of Hetlioz net product sales, and $8.6 million of Ponvory net product sales. For year to date, Q2 2024, we had total revenues of just under $100 million, with operating expenses of approximately $117 million. That resulted in a net loss of about $8.7 million, and again, ending cash balance of just under $390 million. With that, I'd like to thank everybody for their interest in Vanda and look forward to talking to you and providing additional updates in the future.
Thank you so much. Thank you so much, Mr-?